Korean Biopharma Legal

Earlier this year, The 'Korea Pharmaceutical and Bio-Pharma Manufacturers Association(KPBMA)' officially launched the 'Convergence AI Institute for Drug Discovery(CAIID)' and held the grand opening ceremony on January 31st. The South Korean CAIID aims to serve as a hub for jointly planning and executing digital convergence research and aims to establish safe utilization platform for diverse data, which may enhance the performance of AI.  The CAIID's head Hwajong Kim stated, "Currently, pharmaceutical companies are collaborating individually with AI companies. However, there is no perfect match between the data held by pharmaceutical companies and the advantages of each solution provider." He continued, "Since each pharmaceutical company possesses different data, the approach to AI should also vary. However, at this point, we cannot predict this in advance, which limits us." He emphasized, "It is not a stage to debate whether this business wi...

South Korean  GNT Pharma Co. Ltd announced on the 13th of this month, that administering their stroke treatment drug 'Nelonemdaz' to patients within one hour of arrival at the emergency room showed nearly a five-fold improvement in disability compared to a placebo treatment. T he chief investigator of the Phase 3 trial at Seoul Asan Hospital's Neurology Department, presented the key findings at ISC 2024 held at the Phoenix Convention Center in Arizona, USA. It has been reported that  the Phase 3 trial of Nelonemdaz targeted severe stroke patients receiving intravenous thrombolysis within 12 hours of onset. The 496 patients in this trial received medication within 7 hours of onset upon arrival at the emergency room and underwent thrombolysis simultaneously, analyzing disability improvement and safety 12 weeks later.  The efficacy of Nelonemdaz was found to be related to the time of medication administration and thrombolysis. Particularly, among 47 patients who promptly rec...

On the first day of this month, the Ministry of Food and Drug Safety and the biotech industry welcomed the acceptance of the bill adding 'Regenerative Medical Institutions' as human cell management by the National Assembly, amending the 'Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products'.  Human Cell Management businesses are operators who collect, import, inspect, process, and supply human cells, which have been mostly in-house product manufacturers or the blood banks. Now that this amendment has been approved, advanced regenerative medical institutions equipped with facilities, equipment, and personnel similar to the standards for human cell management, shall also be recognized as subjects for permits for the management of human cells. This means that advanced regenerative medical institutions can supply raw materials by performing minimal procedures such as simple isolation, washing, freezing, and thawing of cells ob...

The global competition for Antibody-Drug Conjugate (ADC) technology, a cutting-edge method in anti-cancer drug development, is intensifying. Major global pharmaceutical companies, including Pfizer, AbbVie, and Johnson & Johnson, invested significantly to secure ADC technology. This trend is also evident in South Korea, with companies like Samsung Biologics and Celltrion leading the race to obtain ADC capabilities. ADC involves attaching drugs that can attack cancer cells to antibodies, offering targeted drug delivery for anti-cancer agents. The technology is gaining attention globally, and the ADC market is expected to reach $19.8 billion by 2028. The interest in ADC further increased with the approval of 'Enhertu,' an ADC drug for breast cancer jointly developed by AstraZeneca and   Daiichi Sankyo. Major global pharmaceutical companies are actively involved in ADC technology, with Pfizer's Seagen acquisition being the largest M&A deal in the sector. Korean companie...

The South Korean Government is currently proposing several measures to address regional medical disparities and improve healthcare accessibility, particularly during nighttime and holidays. Here's a summary of the key points; 1. Amendments to Medical Laws  There are proposed amendments to allow the delivery of pharmaceuticals from public late-night pharmacies for non-face-to-face consultations during evenings and holidays. 2. Establishment of Regional Medical Schools  Plans include promoting the establishment of regional medical schools to address the demand and conditions of medically underserved areas. Additionally, there is an intention to enact a 'Special Law for Resolving Regional Medical Disparities' ( 지역 의료 격차 해소 특별법)  to support this effort. 3. Improving Regional Medical Infrastructure  Efforts are underway to enhance regional hub public hospitals with advanced systems and establish a cooperative network between regional national hospitals and public hospital...

As the research and development (R&D) capabilities of Korean pharmaceutical companies significantly improve and new drug development continues, the number of cases of marketing and sales collaboration, such as 'co-promotion' agreements executed for joint sales of drugs has been reported to be increasing. It was reported on the 14th of this month, that a total of 14 cases of marketing and sales collaboration between Korean pharmaceutical companies occurred this year, through co-promotion agreements for joint sales of medicines. List of Korean 'co-promotion' Agreements executed in the year of 2023 Co-promotion has the advantage of allowing developers with weak sales capabilities to leverage the capabilities of other pharmaceutical companies with strong sales capabilities in the field. One example is the joint sales of ‘Zemiglo’ by LG Chem and Daewoong Pharmaceutical, where at the time of approval, LG Chem signed a joint sales agreement with the global pharmaceutical c...

The Korean telemedicine industry has been experiencing significant growth and transformation, spurred by advancements in technology and changes in healthcare delivery models. Although so far, South Korea's regulatory environment has not been so friendly for the telemedicine industry, limiting the scope of telemedicine services, there have been many efforts to expand telemedicine regulations to accommodate technological advancements and changing healthcare needs. During the COVID pandemic, this unprecedented experience has accelerated the adoption of telemedicine globally, including in South Korea. As social distancing measures and lockdowns restricted in-person healthcare visits, telemedicine emerged as a crucial alternative for patients to receive medical advice and treatment while minimizing the risk of virus transmission. As a result, the South Korean government has recognized the potential benefits of telemedicine in improving healthcare accessibility, especially in remote area...

From the 27th of January, 2024, the application of the 'Serious Accident Punishment Act' in South Korea has been finally expanded to workplaces having just 5 to 50 employees. The Serious Accident Punishment Act is a law that punishes people in management for more than a year of imprisonment or fines up to 1 billion won if a serious disaster, such as a fatal accident occurs due to negligence in ensuring safety at the workplace. Since its enactment in 2021, it has been implemented for workplaces with 50 or more employees from January 2022. It is understood that many small pharmaceutical companies have not been fully prepared for the implementation of the Serious Accident Punishment Act; and that most of them have difficulties appointing safety management personnel.  Since there has been a high interest in the application of this Act in many small to mid-size pharmaceutical or life science companies in Korea, I have collaborated with the ' Korea Pharmaceutical and Bio-Pharma M...

Before starting her career as a lawyer providing legal services for Life Science and Pharmaceutical companies, Woojin earned a Ph.D. degree in Neuroscience at the University College London, Institute of Neurology, as a government scholarship recipient and a Master's degree in Oncology at the University of Nottingham,   at the School of Molecular Medical Science  in the U.K.  Woojin is a skilled advisory lawyer sought by many Life Science and Pharmaceutical companies in South Korea, based on her in-depth experience from Life Science research in the laboratory, global clinical trials and working as an IP lawyer before opening her own specialized practice in year 2020.   Woojin also has experience as a professional academic consultant in the field of English Medical Writing and has been recognized for her expertise in lectures for Medical Science Communication. ▲ J.D. at Ewha Law School, Attorney at Law, Patent Attorney (2016) ▲ Ph.D. Neuroscience...